NCT01169181

AMES + Brain Stimulation

AMES + Brain Stimulation: Treatment for Profound Plegia in Stroke

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: AMES Technology · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The procedure involves: (1) assisted hand movement by a mechanical device, (2) mechanical vibration applied to the surface of the forearm, and (3) stimulation of the brain with either transcranial magnetic stimulation (TMS) or transcortical direct current stimulation (DCS). These 3 components of the procedure are carried out simultaneously. Each subject will be evaluated pre- and post-treatment with several clinical tests of functional movement. The hypotheses of this project are that the AMES+rTMS and AMES+tDCS procedures are safe and will enable most of the stroke patients to recover finger extension.

Detailed description

This protocol is designed to investigate the safety and efficacy of a procedure for treating chronic (\>1 year post) stroke patients who still cannot move the hand affected by the stroke. The treatment involves: (1) assisted hand movement by a mechanical device, (2) mechanical vibration applied to the surface of the forearm, and (3) stimulation of the brain with either transcranial magnetic stimulation (TMS) or transcortical direct current stimulation (DCS). Subjects receiving TMS during treatment are expected to respond more fully (i.e., increased volitional EMG) in the treated hand compared to those receiving DCS.

Conditions

• Stroke
• Cerebrovascular Accident
• Plegia

Interventions

Type	Name	Description
DEVICE	AMES + brain stimulation	Stroke survivors with plegia of affected upper extremity receive either AMES + rTMS or AMES + tDCS.

Timeline

• Start date: 2010-07-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2010-07-26
• Last updated: 2016-12-08

Locations

1 site across 1 country: United States